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Prospective, multicenter, controlled study of pancreatic bowel anastomosis based on characteristics of pancreatic tissue

Prospective, multicenter, controlled study of pancreatic bowel anastomosis based on characteristics of pancreatic tissue

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16010219
Enrollment
Unknown
Registered
2016-12-22
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periampullary malignant and benign diseases

Interventions

Severe chronic inflammation:Pancreatic and intestinal anastomosis
Mild to moderate chronic inflammation:Semi encapsulated anastomosis of jejunum U type
Normal pancreas:Complete jejunal anastomosis

Sponsors

Department of Pancreatic Surgery, Center of Digestive&Vascular Medicine, First Affiliated Hospital, Xiniiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. subjects with informed consent; 2. pancreatic head and ampulla lesions underwent pancreatoduodenectomy; 3. male or female subjects, more than 18 years of age, life expectancy of at least 12 weeks; 4. in the 7 days before surgery, suffecient liver and kidney function, laboratory indexes suitable (after treatment): neutrophil 1500/mm3, PLT = 50x10^9/L, ALB = TBIL<2mg/dL, serum 28g/L, ALT, AST<5 times the upper limit of normal value, the upper limit of normal Bun, Cr<1.5 times the value of INR<1.7 or PT extension <4s.

Exclusion criteria

Exclusion criteria: 1. distant organs (liver, lung, abdominal) metastasis has occurred; the common bile duct and hepatic duct metastasis; hepatic portal, common bile duct and pancreatic lymph node metastasis above; tumor involvement of the superior mesenteric artery and celiac trunk; around pancreatic head or ampulla with inferior vena cava or aortic close adhesion; 2. Congestive heart failure 2 > New York Heart Association (NYHA) grade II; 3. had uncontrolled hypertension; 4. human immunodeficiency virus (HIV) infection history; 5. renal failure or renal insufficiency; 6. serious infectious clinical activities of blood or peritoneal dialysis (grade >2, NCI-CTCAE version 4); 7. patients 4 weeks before the emergence of upper gastrointestinal bleeding or clear gastrointestinal bleeding tendency; 8. pregnancy or breast-feeding subjects; 9. before the trial started within 4 weeks after surgery the patients or patients has not yet recovered from the side effects of this kind of operation; 10. with its malignant tumor (he had cure 3 years ago could be included).

Design outcomes

Primary

MeasureTime frame
POPF;

Secondary

MeasureTime frame
Postoperative complication;Delayed Gastric Emptying;Postoperative hospital stay;

Countries

China

Contacts

Public ContactXinjian Xu
xxj0991@163.com+86 18599098380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026